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Completed

NCT Number: NCT03768622

Proximal Femoral Fractures - Patient Population, Risk Factors, Surgical Performance and Outcome

Proximal femoral fractures are a typical pathology in elderly patients after a low-energy trauma.

This study analyses preexisting risk factors for proximal femoral fractures as well as for failing to reach the previous functional level, difference in outcome between patients with femoral neck fracture compared to those with pertrochanteric fracture, surgical performance and its significance for the functional outcome, as well as the impact of proximal femoral fractures on patients' one-year independence.

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Key information

Conditions

Proximal Femoral Fracture Femoral Fractures Femoral Neck Fractures Fractures, Bone Hip Fractures Hip Injuries Leg Injuries Proximal Femoral Fractures Wounds and Injuries

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Orthopaedics and Trauma Surgery (DOTS).

Basel, 4031, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • surgery with intramedullary nail type Gamma® Nail or similar in case of pertrochanteric fractures or
  • with a partial hip arthroplasty in case of femoral neck fractures

Exclusion criteria

  • Clinical follow up at another institution
  • Documented dissent in study participation

Treatment and study plan

surgery for pertrochanteric femoral fracture

Procedure

surgical treatment for proximal femoral fracture with intramedullary nail type Gamma® Nail or similar in case of pertrochanteric fractures

surgery for femoral neck fracture

Procedure

surgical treatment for proximal femoral fracture with a partial hip arthroplasty in case of femoral neck fractures

Primary outcomes

  1. Change in Patient clinical outcome

    Time frame: from date of surgery until 1 year follow up period after surgery

    Quantification of Rehospitalizations

  2. Change in Patient clinical outcome

    Time frame: at 1 year follow up date after surgery

    Change in living situation

  3. Change in Patient clinical outcome

    Time frame: during hospitalization (from date of surgery until discharge date after surgery (approx. 1-3 weeks)

    Quantification of major complications with documentation of affected organ System, intensive care Treatment, Discharge where to (home, home with support, in-patient rehabilitation, nursing home), length of hospital stay

  4. Change in Patient clinical outcome

    Time frame: from date of surgery until 1 year follow up period after surgery

    Quantification of Reoperations

  5. Change in Patient clinical outcome

    Time frame: from date of surgery until 1 year follow up period after surgery

    Quantification of infections

  6. Change in Patient clinical outcome

    Time frame: from date of surgery until 1 year follow up period after surgery

    Quantification of deaths and date of death

  7. Change in Patient clinical outcome

    Time frame: at 1 year follow up date after surgery

    Change in use of walking aids

  8. Change in Patient clinical outcome

    Time frame: at 1 year follow up date after surgery

    Change in pain at rest (yes/no),

  9. Change in Patient clinical outcome

    Time frame: at 1 year follow up date after surgery

    Change in pain under stress (yes/no)

  10. Change in Patient clinical outcome

    Time frame: at 1 year follow up date after surgery

    Change in restrictions in daily living (yes/no),

  11. Change in Patient clinical outcome

    Time frame: at 1 year follow up date after surgery

    Change in use of analgetics (yes/no)

  12. Change in Patient clinical outcome

    Time frame: during hospitalization (from date of surgery until discharge date after surgery (approx. 1-3 weeks)

    Quantification of intensive care Treatment

  13. Change in Patient clinical outcome

    Time frame: during hospitalization (from date of surgery until discharge date after surgery (approx. 1-3 weeks)

    Quantification of Discharge where to (home, home with support, in-patient rehabilitation, nursing home)

  14. Change in Patient clinical outcome

    Time frame: during hospitalization (from date of surgery until discharge date after surgery (approx. 1-3 weeks)

    Quantification of length of hospital stay

Secondary outcomes

  1. Change in patient clinical outcome (according Penrod score)

    Time frame: preoperatively and at 1 year follow up date after surgery

    Penrod score reflects the patients' preoperative functional level and living. Patients are classified concerning their prefracture age (1: <75 years, 2: 75-84 years, 3 ≥85 years, their ability in performing activities of daily life (ADL) as well as their cognitive status (dementia in clusters 2B and 3D Situation)

  2. Change in radiological outcome: assessment of surgical treatment of pertrochanteric fractures

    Time frame: day of surgical intervention (immediately after surgery) and 1year postoperative (if n.a. min 6 months postoperative)

    central positioning and insertion of the neck screw

  3. radiological outcome: assessment of surgical treatment of femoral neck fractures

    Time frame: 1year postoperative (if n.a. min 6 months postoperative)

    development of periacetabular ossification according to Brooker

    • A islands of bone within the soft tissues about the hip
    • B bone spurs originating from the pelvis or proximal end of the femur, leaving at least 1 cm between opposing bone surfaces
    • C bone spurs originating from the pelvis or proximal end of the femur, reducing the space between opposing bone surfaces to less than 1 cm
    • D bone ankylosis of the hip

  4. Change in subsidence (radiological outcome: assessment of surgical treatment of femoral neck fractures)

    Time frame: 1year postoperative (if n.a. min 6 months postoperative)

    differences in the distance between perpendicular lines drawn to the bisecting axis of the medullary canal, at the top of the femoral head and at the tip of the great trochanter in mm

  5. radiological outcome: assessment of surgical treatment of femoral neck fractures

    Time frame: 1year postoperative (if n.a. min 6 months postoperative)

    cortical atrophy i.e. longitudinal intracortical porosis with a consecutive thinning of the cortex without measurable thickening of the femur (yes-no-n.a.)

  6. radiological outcome: assessment of surgical treatment of femoral neck fractures

    Time frame: 1year postoperative (if n.a. min 6 months postoperative)

    osteolysis i.e. progressive, newly developed endosteal bone loss with a diameter > 3 mm, either with scalloping or a bead-shaped lucency at the cement-bone interface

  7. radiological outcome: assessment of surgical treatment of femoral neck fractures

    Time frame: 1year postoperative (if n.a. min 6 months postoperative)

    debonding i.e. radiolucent line at the prosthesis-cement interface not visible on the first postoperative radiograph (yes-no-n.a.)

  8. Change in radiological outcome: assessment of surgical treatment of pertrochanteric fractures

    Time frame: day of surgical intervention (immediately after surgery) and 1year postoperative (if n.a. min 6 months postoperative)

    leg-length discrepancy (tangent to inferior pubic rami and tip of greater trochanter, if n.a. insertion of lesser trochanter)

  9. Change in radiological outcome: assessment of surgical treatment of femoral neck fractures

    Time frame: day of surgical intervention (immediately after surgery) and 1year postoperative (if n.a. min 6 months postoperative)

    leg-length discrepancy in mm (tangent to inferior pubic rami and tip of greater trochanter, if n.a. insertion of lesser trochanter)

  10. Change in radiological outcome: assessment of surgical treatment of femoral neck fractures

    Time frame: day of surgical intervention (immediately after surgery) and 1year postoperative (if n.a. min 6 months postoperative)

    alignment on ap view (central axis of the distal stem to bisecting axis of medullary canal at the isthmus) in °

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Acronym: ProFi

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Dec 7, 2018
Registry last updated
Nov 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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